Background: NAPOLI-1 (NCT01494506) was a global phase 3 trial of pts with mPDAC that progressed following gemcitabine-based therapy. Median OS (mOS) for nal-IRI+5-FU/LV was 6.1 vs 4.2 months (mo) for 5-FU/LV (unstratified HR = 0.67; P = 0.012). Here, we present four separate post-hoc subgroup analyses exploring baseline (BL) parameters. Methods: We evaluated outcomes in pts with or without BL metabolism and nutrition disorders (hypercholesterolemia and decreased appetite [=anorexia, poor appetite, lack of appetite and loss of appetite]), by primary tumour location (PTL), with or without a biliary stent at BL, and by best response to prior therapy (complete response/partial response [CR/PR] vs not-CR/PR, and CR/PR/stable disease [CR/PR/SD] vs not-CR/PR/SD). Results: For ITT pts, decreased appetite at BL significantly reduced mOS (n = 77) vs without (n = 340) (3.6 vs 5.3 mo; HR = 1.65; P < 0.001). We observed a trend for lower mOS with hypercholesterolemia. PTL (e.g. incl./excl. pancreatic head) had no prognostic effect on mOS after trial inclusion (HRs=0.87–1.06). ITT pts with (n = 37) and without (n = 380) biliary stent at BL had comparable mOS (5.3 vs 4.8 mo; HR = 0.97). Pts with (n = 15) and without stent (n = 102) and receiving nal-IRI+5-FU/LV had similar mOS (6.2 vs 6.1 mo; HR = 0.44). mOS in pts with CR/PR was 5.6 mo vs 4.8 mo in not-CR/PR (HR = 0.73). CR/PR/SD was similar to not-CR/PR/SD (mOS both 4.9 mo, HR = 0.95). Pts with nal-IRI+5-FU/LV with CR/PR (n = 11) had a mOS of 9.3 mo vs 6.1 mo in not-CR/PR (n = 106; HR = 0.64). mOS in CR/PR/SD and non-CR/PR/SD was similar (HR = 1.04). mOS and mPFS were increased with nal-IRI+5-FU/LV for all subgroups vs 5-FU/LV (those with n > 10 per arm). Within subgroups, drug-related AEs and dose modifications/discontinuations were generally comparable to NAPOLI-1. Conclusions :Decreased appetite at BL was prognostic for survival in NAPOLI-1 pts. We found no significant prognostic effect of other subgroups in either the NAPOLI-1 ITT or the nal-IRI+5-FU/LV treatment populations on survival after trial inclusion. Pts benefitted from nal-IRI+5-FU/LV treatment vs 5-FU/LV across subgroups.
Date:
2018-11
Relation:
Annals of Oncology. 2018 Nov;29(Suppl. 9):Meeting Abstract 200P.
